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Current Good Clinical Practices (cGCP)

Software for Assuring that Your Company Meets the Requirements for Current Good Clinical Practices (cGCP)

The stringent regulations for establishing, implementing, and maintaining compliance with Current Good Clinical Practice (cGCP) regulations can seem daunting. Companies face many challenges in controlling required documentation during all clinical phases. With MasterControl the process of satisfying the compliance requirements for cGCP can become an easily manageable part of corporate culture.

For more than two decades, MasterControl has provided configurable and easy-to-use quality management software solutions that keep companies connected and properly aligned with cGCP requirements, like the ICH GCP E6 R2 Addendum, which encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.

White Paper: How Quality and Compliance Can Help Reduce the Cost and Time Involved in Executing Clinical Trials

White Paper: Automating Quality Compliance and Business Process within the Food and Beverage Industry

Product Data Sheet: MasterControl GLP Studies™

Product Data Sheet: MasterControl GCP Studies™

Product Data Sheet: MasterControl Clinical Quality (GCP) JumpStart

Toolkit: Clinical Management Toolkit from MasterControl

Meeting the Requirements of cGCP

Meeting the full requirements of cGCP in an efficient manner entails that companies establish and maintain compliant, connected, and complete clinical quality systems.

Compliant: By automating clinical quality processes, MasterControl helps companies attain compliance and sustain it year after year. MasterControl also provides the resources companies need to validate their cGCP-focused software solution.

Connected: MasterControl connects clinical professionals with the data and processes they need to see the "big picture." The holistic MasterControl approach encourages collaboration and allows managers to view and monitor their entire quality system.

Complete: MasterControl helps companies realize compliance as a part of their corporate culture so they can sustain compliance throughout every department across the enterprise.

For More Information on Current Good Clinical Practices (cGCP)

For more information about cGCP requirements and how MasterControl can help your organization achieve and sustain compliance according to the FDA-established cGCP guidelines, please feel free to contact aMasterControl representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).